Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin
Conditions
Unresectable Intrahepatic Cholangiocarcinoma
Conditions: official terms
Cholangiocarcinoma - Liver Neoplasms
Conditions: Keywords
LC Bead, Irinotecan
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LC Bead with Gem-Cis Type: Device
Name: Gemcitabine and Cisplatin Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion:

- Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible

- Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria)

- Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver

- Non-pregnant with an acceptable contraception in premenopausal women.

- Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria)

- Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl,

- Adequate renal function (creatinine ≤ 2.3 mg/dl)

- Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age)

- Signed, written informed consent

- Less than 70% of liver parenchymal tumor replacement

Exclusion:

- Patient eligible for curative treatment (i.e. resection or tumor ablation).

- Active bacterial, viral or fungal infection within 72 hours of study entry

- Women who are pregnant or breast feeding

- ECOG Performance Status score of >3

- Life expectancy of < 3 months

- Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated

- Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin.

- Any contraindication for hepatic embolization procedures:

- Large shunt as determined by the investigator (pretesting with TcMMA not required)

- Severe atheromatosis vascular disease that precludes arterial cannulization

- Hepatofugal blood flow

- Main portal vein occlusion (e.g. thrombus or tumor)

- Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation

- Patients with prior contraindications for the use of irinotecan, gemcitabine, or cisplatin

- Patients who have received prior systemic therapy with either irinotecan, gemcitabine, or cisplatin
Location
University of Louisville
Louisville, Kentucky, United States
Status: Recruiting
Contact: Melissa Schlegel, CRC - 502-629-3383 - melissa.schlegel@louisville.edu
Start Date
July 2012
Completion Date
July 2016
Sponsors
University of Louisville
Source
University of Louisville
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page